Keep Your Documentation Rolling

Keep Your Documentation Rolling

This is the third post in a multipart series on how medical device and pharmaceutical companies can continue to make progress on Human Factors-related activities during the COVID-19 crisis.

Now is the perfect opportunity to devote the time that you might normally have spent traveling to observe or prepare for face-to-face research to developing critical program documentation. 

Human Factors programs rely on robust documentation that traces to your activities but also to the design and labeling mitigations you’ve developed. Consider developing or refining your human factors engineering plan, use specification, use-related risk analysis, etc. Remember that these documents are considered “living documents” that should be updated as a product develops and matures, so taking the time to review them periodically is prudent and can save you from scrambling in the future.

Another opportunity is to meet your post-market surveillance commitments by reviewing your complaints data, searching the public databases for adverse events and potential use-issues, and incorporating this information into your use-related risk analysis.

And for those of you developing generics or biosimilars, there is plenty of documentation to work on as well. For example, this is a prime time to conduct your comparative threshold analysis. The outcome of this analysis will provide critical information needed to help the direction of your program.  

Give us a call to see how we can assist you with your documentation.